The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) have announced a new initiative designed to streamline patient access to innovative medical technologies. The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway seeks to accelerate Medicare coverage for certain FDA-designated Class II and Class III Breakthrough Devices.
The program is intended to address longstanding delays between FDA market authorization and Medicare national coverage determinations (NCDs), which can often take a year or more. Under RAPID, that timeline could be reduced to as little as two months.
“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” said CMS Administrator Mehmet Oz, MD, MBA. “The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster.”
Earlier alignment on evidence requirements
A key feature of RAPID is earlier collaboration between CMS, FDA, and device manufacturers during the development lifecycle. CMS will participate in early discussions to help define clinical evidence requirements relevant to Medicare beneficiaries, allowing data generated for FDA review to also support coverage decisions.
Eligible devices must be part of an Investigational Device Exemption study that includes Medicare beneficiaries and evaluates clinical outcomes agreed upon by both agencies. The pathway applies to certain Class II devices in the FDA’s Total Product Life Cycle Advisory Program, as well as Class III devices regardless of participation in that program.
What are Class II and Class III Breakthrough Devices? |
Class II devices are moderate-risk medical devices that require regulatory controls to ensure safety and effectiveness. Class III devices are high-risk devices that typically support or sustain life or are implanted, and require the most rigorous FDA review. When designated as “Breakthrough Devices,” both Class II and Class III products are prioritized for faster development and review because they may offer significant improvements over existing options for serious or life-threatening conditions. |
By aligning evidentiary expectations upfront, the agencies aim to reduce duplication, improve efficiency, and increase transparency for developers.
“The American people deserve timely access to meaningful treatments without red tape or high costs," said FDA Commissioner Marty Makary, MD, MPH. "In this administration, FDA and CMS are functioning as a single team to deliver life-saving Breakthrough Devices to American patients as soon as we know they work.”
Toward more predictable coverage timelines
The RAPID pathway also introduces a synchronized review process. CMS plans to issue a proposed NCD on the same day a qualifying device receives FDA authorization, initiating a 30-day public comment period.
CMS noted that the Transitional Coverage for Emerging Technologies pathway will be paused for new candidates as the agency prioritizes RAPID implementation. A proposed procedural notice is expected to be published in the Federal Register, with a 60-day public comment period to follow.
Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.
